Randomised crossover trial to determine whether a beta blocker and an Angiotensin Converting Enzyme (ACE) inhibitor have independent effects in lowering blood pressure
| ISRCTN | ISRCTN97280940 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97280940 |
| Protocol serial number | P3/04/040 |
| Sponsor | Queen Mary University of London (UK) |
| Funder | Investigator-funded (UK) |
- Submission date
- 02/03/2007
- Registration date
- 16/05/2007
- Last edited
- 03/05/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr David Wald
Scientific
Scientific
Wolfson Institute of Preventive Medicine
Charterhouse Square
London
EC1 M6BQ
United Kingdom
| d.s.wald@qmul.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, placebo-controlled, crossover trial. |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | CTBP (Combination Therapy Blood Pressure) Trial |
| Study objectives | Randomised, crossover trial to determine whether a beta blocker and an ACE inhibitor have independent effects in lowering blood pressure. |
| Ethics approval(s) | East London Local Research Ethics Committee on 04/05/2004 (ref: DAI/MY/P304040) |
| Health condition(s) or problem(s) studied | Cardiovascular disease |
| Intervention | All participants received each of the following interventions: 1. Atenolol 25 mg 2. Lisinopril 5 mg 3. Atenolol 25 mg + lisinopril 5 mg 4. Placebo sequentially in a random sequence. |
| Intervention type | Other |
| Primary outcome measure(s) |
Systolic and diastolic blood pressure. |
| Key secondary outcome measure(s) |
Adverse effects. |
| Completion date | 14/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 60 |
| Key inclusion criteria | 1. Men or women over age 40 2. Blood presssure over 100/60 mmHg |
| Key exclusion criteria | 1. Peripheral vascular disease 2. Asthma 3. Atrial Fibrillation (AF) |
| Date of first enrolment | 14/04/2004 |
| Date of final enrolment | 14/12/2004 |
Locations
Countries of recruitment
- United Kingdom
Study participating centre
Wolfson Institute of Preventive Medicine
London
EC1 M6BQ
United Kingdom
EC1 M6BQ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2008 | Yes | No |
